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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00882609
Other study ID # AMI-2008-01
Secondary ID
Status Recruiting
Phase Phase 3
First received April 15, 2009
Last updated November 28, 2012
Start date January 2009
Est. completion date June 2013

Study information

Verified date November 2012
Source American College of Radiology - Image Metrix
Contact Johannes Czernin, MD
Phone (310) 983-1443
Email JCzernin@mednet.ucla.edu
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The primary objective is to compare the diagnostic performance of 18F- Fluoride PET/CT scanning to that of conventional bone scanning for detecting cancer that has spread to the bone (bone metastasis). The intent of the study is to determine whether 18F-Fluoride PET/CT will lead to improved treatment and patient outcomes.


Description:

The trial will accrue four hundred-eighty eight (488) evaluable patients with breast cancer, prostate cancer or lung cancer (approximately 163 of each cancer type) referred for routine bone scanning by their respective physicians. The specific stages of cancer required for eligibility are described in the eligibility criteria.

Approximately eleven to fifteen qualified clinical centers will participate in the trial, with target enrollment for each site set at roughly 40-50 patients per site.

The images of the patients will be transmitted to ACR Image Metrix, an imaging contract research organization (iCRO), for quality assurance and archival. iCRO will conduct blinded core lab interpretations by 3 radiologists who have not been involved in the design of the trial nor the clinical image interpretation. The data from the core lab readings will be compared with the deliberations of a multidisciplinary panel of oncology experts who will be blinded to the initial scan results and will determine the standard of evidence (truth) for each patient. The analysis will be based on this comparison.


Recruitment information / eligibility

Status Recruiting
Enrollment 550
Est. completion date June 2013
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patient is = 18 years old at the time of the drug administration (Patient may be male or female of any race / ethnicity.)

- Patient or patient's legally acceptable representative cognitively provides written informed consent

- Patients without known bone metastases who are newly diagnosed with = stage 3 breast cancer, = stage 3 lung cancer, or = stage 2 prostate cancer (and/or PSA >10 micrograms/L), including patient with recurrent breast, lung or prostate cancer

- Patient is scheduled to undergo a conventional bone scan

- Patient is capable of complying with study procedures

- Patient is able to remain still for duration of imaging procedure (about one hour)

- Patient may have had a prior PET or PET/CT scan for staging/restaging.

Exclusion Criteria:

- Patient is < 18 years old at the time of the drug administration

- Patient is pregnant or nursing;

- testing on site at the institution (urine or serum ßHCG) within 24 hours prior to the start of investigational product administration

- obtaining surgical history (e.g., tubal ligation or hysterectomy)

- confirming the subject is post menopausal, with a minimum 1 year without menses

- Patient has any other condition or personal circumstance that, in the judgment of the investigator, might interfere with the collection of complete good quality data

- Patient has known bone metastases

- Patient has previously received [18F]NaF in the last thirty days

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic


Intervention

Device:
Bone Scan: F18-Fluoride PET/CT or TC-MDP
Each patient will be randomized into one of two groups with one group receiving Sodium Fluoride F18 Injection and the other receiving the control agent, 99mTc-MDPSodium Fluoride F18 Injection Dosing and Administration. The dose will be tailored for the specific patient for whom the dose was ordered. The dose of Sodium Fluoride F18 Injection administered will range from 5-10 mCi/patient.Each patient randomized to the control group will be administered 99mTc-MDP as a single intravenous bolus dose. The administered radioactivity will be determined based on the sites routine clinical practice for conventional bone imaging.

Locations

Country Name City State
Australia Peter MacCallum Melbourne Victoria
Austria PET-CT Linz - St. Vicent's Hospital Linz
Portugal Hospitais da Universidade de Coimbra Coimbra
Switzerland University Hospital Zurich Zurich
United States University of Michigan Health System Ann Arbor Michigan
United States Silicon Valley Imaging Freemont California
United States University of Texas MD Anderson Cancer Center Houston Texas
United States Saint Luke's Hospital Kansas City Missouri
United States Dartmouth-Hitchcock Medical Center Lebanon New Hampshire
United States Cedar-Sinai Medical Center Los Angeles California
United States UCLA Los Angeles California
United States VA West Los Angles Medical Center Los Angeles California
United States New York Presbyterian Weill Cornell New York New York
United States John Cochran Veterans Administration Saint Louis Missouri
United States Saint Louis University Saint Louis Missouri
United States University of Utah School of Medicine Salt Lake Utah
United States SouthCoast Imaging Center Savannah Georgia
United States Scottsdale Medical Imaging Scottsdale Arizona
United States Stanford University Medical Center Stanford California

Sponsors (2)

Lead Sponsor Collaborator
American College of Radiology - Image Metrix World Molecular Imaging Society

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Portugal,  Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Analysis of the diagnostic performance of [18F]NaF fluoride PET/CT scanning The primary endpoint will be an analysis of the diagnostic performance of [18F]NaF fluoride PET/CT scanning to that of conventional bone scanning for detecting cancer that has spread to the bone (bone metastasis). The hypothesis is that PET/CT is superior to conventional bone scanning for detecting bone metastases. The primary metrics used for comparison will be the relative areas under the ROC curves generated by blinded core lab interpretations of the scans. 6 Months No
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